Vaccine Development and Manufacturing

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.

Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.

The new facility, which is expected to be operational by mid-2026, will utilize cell-based technology to produce influenza vaccines for influenza pandemics and seasonal vaccination programs, both in Australia and globally.

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

Interim efficacy data suggests the Pfizer/BioNTech mRNA-based vaccine has an efficacy rate above 90%.

Biopharma can apply new manufacturing practices adopted during the COVID-19 pandemic to enhance bioprocessing.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

In the wake of its efforts to develop a COVID-19 vaccine candidate, the company has secured two additional properties in the Gaithersburg, MD area.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

The companies have signed a Statement of Intent with Gavi to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine available for distribution.

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

The facility will include a high-speed sterile line for live virus filling, a line for standard fill/finish, cleanroom capacity, labs, warehousing, and offices to support production.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians.

The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Misleading messages contribute to eroding trust in public health agencies

The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.

The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.